A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation

NCT04359004 | Completed DMC

• 2 other identifiers: 19-001929OT2OD028201
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. The outcomes of this study will help researchers design new therapies for patients that have complex and life-threatening ventricular arrhythmias.

Conditions

Arrhythmia; Ventricular Tachycardia (VT)

Keywords

Arrhythmia; Vagus Nerve Stimulation (VNS); Activation Recovery Interval (ARI)

Outcome Measures

Primary Outcomes (1)

• The change in ventricular action potential duration during stimulation compared to baseline in msec

  Up to 30 minutes or completion of the vagus nerve stimulation

Secondary Outcomes (2)

• The change in blood pressure during stimulation compared to baseline in mmHg.

  Up to 30 minutes or completion of the vagus nerve stimulation

• The change in heart rate during stimulation compared to baseline in beats per minute

  Up to 30 minutes or completion of the vagus nerve stimulation

Interventions

Vagus Nerve Stimulation (VNS) OTHER

Vagus Nerve Stimulation (VNS) will be performed percutaneously through the internal jugular vein during the patient's routine VT ablation procedure. The nerve will be stimulated using standard pacing systems used for clinical purposes. A series of stimulation frequencies and pulse widths will be used to define optimal effects and 'dosing'. Activation recovery interval (ARI) will be measured from the unipolar electrograms. In addition, heart rate and blood pressure responses will be continuously recorded.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
• Age \> 18 years old
• Underlying sinus rhythm with heart rate \> 50 bpm.
• Provision of signed/dated informed consent and stated willingness to comply with all study procedures

You may not qualify if:

• Status post orthotopic heart transplantation
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
• Unable or unwilling to comply with protocol requirements.
• Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT.
• Known peripheral neuropathy or history of autonomic dysfunction due to non-cardiac causes.
• New York Heart Association Class IV heart failure or use of current vasopressor medications
• Incessant VT
• Persistent atrial fibrillation
• Frequent premature atrial or ventricular contractions
• Inability to give informed consent.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UCLA Health

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Vaseghi M, Salavatian S, Rajendran PS, Yagishita D, Woodward WR, Hamon D, Yamakawa K, Irie T, Habecker BA, Shivkumar K. Parasympathetic dysfunction and antiarrhythmic effect of vagal nerve stimulation following myocardial infarction. JCI Insight. 2017 Aug 17;2(16):e86715. doi: 10.1172/jci.insight.86715. eCollection 2017 Aug 17.

  PMID: 28814663 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Tachycardia, Ventricular

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Kalyanam Shivkumar, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, UCLA Cardiac Arrhythmia Center & EP Programs

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 24, 2020
• Study Start: December 8, 2020
• Primary Completion: June 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)